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Anti-diabetic agent

1 for Type 2 Diabetes (ASI-DMII Trial)

Phase 2
Waitlist Available
Led By Prem Nandiwada, MD
Research Sponsored by American Scitech International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

ASI-DMII Trial Summary

Rationale: RAS 130 is an anti-diabetic agent used to lower the blood glucose level in Type II Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and exercise. RAS 130 works by restoring proper response to insulin in the body. RAS 130 acts primarily by increasing insulin sensitivity which improves glycemic index. It is presumed that RAS 130 does not cause cardiovascular side effects if it is given to Type II diabetes mellitus patients leading a healthy life style. Specifically, controlling diet is done according to American Diabetic Association & American Heart Association guidelines and also through doing aerobic exercises. Guideline for aerobic exercise is given in the design of the study. Exercise is helpful in controlling body weight which can lower the risk for heart disease. Diabetes itself is one of the compounding factors for heart diseases. Exercise helps lowering the LDL cholesterol and raising the HDL cholesterol which is required to prevent heart diseases and achieve a better quality of life. Purpose: The aim of this study is to prospectively assess and evaluate the cardiovascular side effects and reduction of blood glucose levels in the Type II Diabetes mellitus patients treated with RAS 130, who either met, or failed to meet criteria for diet and exercise.

Eligible Conditions
  • Type 2 Diabetes

ASI-DMII Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine cardiovascular side effects such as coronary artery disease (CAD) and congestive heart failure (CHF) in patients treated with RAS 130 along with diet and exercise.
Secondary outcome measures
To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise

ASI-DMII Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
All subjects will take RAS 130 administered orally in tablet form at a starting dose of 4 mg once a day or 2 mg tablets twice a day.

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Who is running the clinical trial?

American Scitech InternationalLead Sponsor
5 Previous Clinical Trials
2,350 Total Patients Enrolled
Proactive Clinical ResearchUNKNOWN
Ratna Grewal, MDStudy ChairAmerican Scitech International - eCRO
3 Previous Clinical Trials
1,030 Total Patients Enrolled

Frequently Asked Questions

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~33 spots leftby Apr 2025